Comment: Several commenters questioned whether or not DHHS has standing to issue binding advisory opinions and recommended that the Department clarify this issue before implementation of this regulation. One respondent suggested that the Department clarify in the final rule the legal issues on which it will opine in advisory opinion requests, and state that in responding to requests for advisory opinions the Department will not opine on the preemptive force of ERISA with respect to state laws governing the privacy of individually identifiable health information, since interpretations as to the scope and extent of ERISA's preemption provisions are outside of the Department's jurisdictional authority.

One commenter asked whether a state could enforce a state law which the Secretary had indicated through an advisory opinion is preempted by federal law. This commenter also asked whether the state would be subject to penalties if it chose to continue to enforce its own laws.

Response: As discussed above, in part for reasons raised by these comments, the Department has decided not to have a formal process for issuing advisory opinions, as proposed.

Several of these concerns, however, raise issues of broader concern that need to be addressed. First, we disagree that the Secretary lacks legal authority to opine on whether or not state privacy laws are preempted. The Secretary is charged by law with determining compliance, and where state law and the federal requirements conflict, a determination of which law controls will have to be made in order to determine whether the federal standard, requirement, or implementation specification at issue has been violated. Thus, the Secretary cannot carry out her enforcement functions without making such determinations. It is further reasonable that, if the Secretary makes such determinations, she can make those determinations known, for whatever persuasive effect they may have.

The questions as to whether a state could enforce, or would be subject to penalties if it chose to continue to enforce, its own laws following a denial by the Secretary of an exception request under § 160.203 or a holding by a court of competent jurisdiction that a state privacy law had been preempted by a contrary federal privacy standard raise several issues. First, a state law is preempted under the Act only to the extent that it applies to covered entities; thus, a state is free to continue to enforce a "preempted" state law against non-covered entities to which the state law applies. If there is a question of coverage, states may wish to establish processes to ascertain which entities within their borders are covered entities within the meaning of these rules. Second, with respect to covered entities, if a state were to try to enforce a preempted state law against such entities, it would presumably be acting without legal authority in so doing. We cannot speak to what remedies might be available to covered entities to protect themselves against such wrongful state action, but we assume that covered entities could seek judicial relief, if all else failed. With respect to the issue of imposing penalties on states, we do not see this as likely. The only situation that we can envision in which penalties might be imposed on a state would be if a state agency were itself a covered entity and followed a preempted state law, thereby violating the contrary federal standard, requirement, or implementation specification.

Section 160.204(b) - Process for Advisory Opinions

Comment: Several commenters stated that it was unclear whether a state would be required to submit a request for an advisory opinion in order for the law to be considered more stringent and thus not preempted. The Department should clarify whether a state law could be non-preempted even without such an advisory opinion. Another commenter requested that the final rule explicitly state that the stricter rule always applies, whether it be state or federal, and regardless of whether there is any conflict between state and federal law.

Response: The elimination of the proposed process for advisory opinions renders moot the first question. Also, the preceding response clarifies that which law preempts in the privacy context (assuming that the state law and federal requirement are "contrary") is a matter of which one is the "more stringent." This is not a matter which the Secretary will ultimately determine; rather, this is a question about which the courts will ultimately make the final determination. With respect to the second comment, we believe that § 160.203(b) below responds to this issue, but we would note that the statute already provides for this.

Comment: Several commenters supported the decision to limit the parties who may request advisory opinions to the state. These commenters did not believe that insurers should be allowed to request an advisory opinion and open every state law up to challenge and review.

Several commenters requested that guidance on advisory opinions be provided in all circumstances, not only at the Secretary's discretion. It was suggested that proposed § 160.204(b)(2)(iv) be revised to read as follows: "A state may submit a written request to the Secretary for an advisory opinion under this paragraph. The request must include the following information: the reasons why the state law should or should not be preempted by the federal standard, requirement, or implementation specification, including how the state law meets the criteria at § 160.203(b)."

Response: The decision not to have a formal process for issuing advisory opinions renders these issues moot.

Sections 160.203(c) and 160.203(d) - Statutory Carve-Outs

Comment: Several commenters asked that the Department provide more specific examples itemizing activities traditionally regulated by the state that could constitute "carve-out" exceptions. These commenters also requested that the Department include language in the regulation stating that if a state law falls within several different exceptions, the state chooses which determination exception shall apply.

Response: We are concerned that itemizing examples in this way could leave out important state laws or create inadvertent negative implications that laws not listed are not included. However, as explained above, we have designed the types of activities that are permissive disclosures for public health under § 164.512(b) below in part to come within the carve-out effected by section 1178(b); while the state regulatory activities covered by section 1178(c) will generally come within § 164.512(d) below. With respect to the comments asking that a state get to "choose" which exception it comes under, we have in effect provided for this with respect to exceptions under section 1178(a)(2)(A), by giving the state the right to request an exception under that section. With respect to exceptions under section 1178(a)(2)(B), those exceptions occur by operation of law, and it is not within the Secretary's power to "let" the state choose whether an exception occurs under that section.

Comment: Several commenters took the position that the Secretary should not limit the procedural requirements in proposed § 160.204(a) to only those applications under proposed § 160.203(a). They urged that the requirements of proposed § 160.204(a) should also apply to preemption under sections 1178(a)(2)(B), 1178(b) and 1178(c). It was suggested that the rules should provide for exception determinations with respect to the matters covered by these provisions of the statute; such additional provisions would provide clear procedures for states to follow and ensure that requests for exceptions are adequately documented.

A slightly different approach was taken by several commenters, who recommended that proposed § 160.204(b) be amended to clarify that the Secretary will also issue advisory opinions as to whether a state law constitutes an exception under proposed §§ 160.203(c) and 160.203(d). This change would, they argued, give states the same opportunity for guidance that they have under § 160.203(a) and (b), and as such, avoid costly lawsuits to preserve state laws.

Response: We are not taking either of the recommended courses of action. With respect to the recommendation that we expand the exception determination process to encompass exceptions under sections 1178(a)(2)(B), 1178(b), and 1178(c), we do not have the authority to grant exceptions under these sections. Under section 1178, the Secretary has authority to make exception determinations only with respect to the matters covered by section 1178(a)(2)(A); contrary state laws coming within section 1178(a)(2)(B) are preempted if not more stringent, while if a contrary state law comes within section 1178(b) or section 1178(c), it is not preempted. These latter statutory provisions operate by their own terms. Thus, it is not within the Secretary's authority to establish the determination process which these comments seek.

With respect to the request seeking advisory opinions in the section 1178(b) and 1178(c) situations, we agree that we have the authority to issue such opinions. However, the considerations described above that have led us not to adopt a formal process for issuing advisory opinions in the privacy context apply with equal force and effect here.

Comment: One commenter argued that it would be unnecessarily burdensome for state health data agencies (whose focus is on the cost of healthcare or improving Medicare, Medicaid, or the healthcare system) to obtain a specific determination from the Department for an exception under proposed § 160.203(c). States should be required only to notify the Secretary of their own determination that such collection is necessary. It was also argued that cases where the statutory carve-outs apply should not require a Secretarial determination.

Response: We clarify that no Secretarial determination is required for activities that fall into one of the statutory carve-outs. With respect to data collections for state health data agencies, we note that provision has been made for many of these activities in several provisions of the rules below, such as the provisions relating to disclosures required by law (§ 164.512(a)), disclosures for oversight (§ 164.512(d)), and disclosures for public health (§ 164.512(b)). Some disclosures for Medicare and Medicaid purposes may also come within the definition of health care operations. A fuller discussion of this issue appears in connection with § 164.512 below.

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